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临床试验/NCT07280962
NCT07280962已完成不适用

Comparison of Outcomes Between Packing Versus no Packing in Perianal Abscess Cavity After Incision and Drainage

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Post-operative Pain

研究概览

简要总结

Perianal abscess is a common surgical emergency that causes significant pain and discomfort. The standard treatment involves incision and drainage (I&D) of the abscess cavity, traditionally followed by packing to prevent re-accumulation of pus and to promote healing. However, packing is often painful, requires frequent dressing changes, and increases patient discomfort as well as healthcare costs. Recent studies suggest that leaving the cavity unpacked may result in similar healing outcomes while reducing postoperative pain and shortening the length of hospital stay. This randomized controlled trial aims to compare the outcomes of packing versus no packing of the perianal abscess cavity following I&D. The study will evaluate postoperative pain using the Visual Analogue Scale at 6, 12, and 24 hours, duration of hospital stay, and the recurrence rate within one month. The findings of this research are expected to guide evidence-based clinical practice by improving patient comfort, reducing hospital burden, and optimizing postoperative care protocols.

详细描述

This randomized controlled trial is designed to evaluate and compare the clinical outcomes of packing versus no packing of the perianal abscess cavity following incision and drainage (I&D), the standard surgical management for this common anorectal condition. Perianal abscesses develop due to infection and obstruction of the anal glands, resulting in severe pain, swelling, and systemic discomfort. Traditionally, postoperative packing of the abscess cavity has been performed to maintain drainage, achieve hemostasis, and prevent re-accumulation of pus; however, this practice is associated with considerable pain, delayed wound healing, repeated dressing changes, and increased hospital visits. In contrast, leaving the cavity unpacked and allowing healing by secondary intention may minimize patient discomfort, reduce healthcare costs, and shorten recovery time without increasing the risk of recurrence.

This study will be conducted among adult patients diagnosed with perianal abscess requiring I&D, who will be randomly assigned to two groups: Group A (packing) and Group B (no packing). Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 6, 12, and 24 hours after the procedure. The duration of hospital stay and recurrence of the abscess within one month will also be recorded. Data will be analyzed using SPSS software, applying independent t-tests and chi-square tests to determine statistical significance, with a p-value < 0.05 considered significant. The findings of this study are expected to provide evidence-based insights into whether non-packing offers comparable or superior outcomes to conventional packing, ultimately guiding surgical practice toward safer, more comfortable, and cost-effective patient care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting in the emergency department diagnosed with acute perianal abscess (Diagnosed on the basis of history and clinical examination with ultrasonographic evidence of quantifiable collection and confirmed by needle aspiration of pus from swelling) based on history and examination, requiring incision and drainage.

排除标准

  • Patients with prior perianal fistulas based on history and examination
  • Patients with recurrent abscess (based on history)
  • Horseshoe abscess as based on examination
  • Previous pelvic irradiation (based on history)
  • Immunocompromised patients
  • Malignant abscess

结局指标

主要结局

Post-operative Pain

时间窗: 24 hours

Patients was assessed for the post-operative pain by using VAS. VAS is a tool used to assess the intensity of pain in patients. The scoring ranges from 0-10, where 0 is minimum or no pain and 10 is maximum pain.

次要结局

  • Recurrence(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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